Product Code: DBF FDA class 2 21 CFR 866.5340

Ferritin, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring ferritin, the primary intracellular iron storage protein, in patient serum or plasma for assessment of iron deficiency, iron overload, and inflammatory states. The kit includes antigen, antiserum, and control components for immunoassay use in clinical laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DBF, regulated under 21 CFR 866.5340, within the Immunology specialty.

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Basic Information

Product Code: DBF
Device Class: FDA class 2
Regulation Number: 866.5340
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 87 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K193650	LIAISON Ferritin	Sep 14, 2021	Substantially Equivalent	DiaSorin, Inc.
K191562	Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor	Mar 06, 2020	Substantially Equivalent	HORIBA ABX SAS
K171642	Atellica IM Ferritin Assay	Aug 31, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133083	DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET	Jun 24, 2014	Substantially Equivalent	Diazyme Laboratories
K121232	K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR	May 24, 2012	Substantially Equivalent	Kamiya Biomedical Company
K110736	ADVIA CHEMISTRY FERRITIN (FRT) METHOD	Aug 17, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K100538	TINA-QUANT FERRITIN GEN. 4	Jun 22, 2010	Substantially Equivalent	Roche Diagnostics
K092505	BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203	Dec 11, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K062746	FERRITIN-LATEX, MODELS 1418-2070, 1418-0279	Nov 20, 2006	Substantially Equivalent	Medicon Hellas S.A
K053211	RDI HSFERRITIN KIT	Mar 13, 2006	Substantially Equivalent	Reference Diagnostics, Inc.
K052617	FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,	Feb 23, 2006	Substantially Equivalent	Good Biotech Corp.
K050944	K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET	Dec 23, 2005	Substantially Equivalent	Kamiya Biomedical Co.
K040879	QUANTEX FERRITIN	May 10, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K031650	FERRITIN GENERATION 2	Jul 17, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K030124	OLYMPUS FERRITIN REAGENT	Feb 06, 2003	Substantially Equivalent	Olympus America, Inc.
K014293	K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET	Feb 19, 2002	Substantially Equivalent	Kamiya Biomedical Co.
K000662	RANDOX FERRITIN	Apr 03, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K993273	N LATEX FERRITIN	Nov 23, 1999	Substantially Equivalent	Dade Behring, Inc.
K992517	BIOCHECK FERRITIN ELISA MODEL BC-1025	Sep 24, 1999	Substantially Equivalent	Biocheck, Inc.
K992157	CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY	Aug 05, 1999	Substantially Equivalent	Chiron Diagnostics Corp.
K984186	NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY	Feb 02, 1999	Substantially Equivalent	Nichols Institute Diagnostics
K983340	IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR	Dec 14, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K983759	ABBOTT ARCHITECT FERRITIN	Dec 07, 1998	Substantially Equivalent	Abbott Laboratories
K982714	BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY	Oct 22, 1998	Substantially Equivalent	Bayer Corp.
K974505	AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501	Feb 17, 1998	Substantially Equivalent	Alfa Biotech (Uk) , Ltd.
K973331	VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)	Oct 22, 1997	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K973202	MODIFICATION OF OPUS FERRITIN TEST SYSTEM	Sep 12, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K970612	SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY	Jun 24, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K963170	OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT	Dec 02, 1996	Substantially Equivalent	Olympus America, Inc.
K951993	UBI MAGIWEL FERRITIN QUANTITATIVE	Jul 05, 1995	Substantially Equivalent	United Biotech, Inc.
K952286	AMERLITE FERRITIN II ASSAY	Jun 20, 1995	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K950707	N LATEX FERRITIN	Mar 27, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K935847	AXSYM FERRITIN	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K935528	DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH	Jan 28, 1994	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K931576	VISTA FERRITIN ASSAY	Aug 05, 1993	Substantially Equivalent	Syva Co.
K924858	AIA-PACK FER CALIBRATION VERIFICATION TEST SET	Dec 15, 1992	Substantially Equivalent	Tosoh Medics, Inc.
K920952	VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY	Apr 07, 1992	Substantially Equivalent	Vitek Systems, Inc.
K920046	MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT	Jan 28, 1992	Substantially Equivalent	Medix Biotech, Inc.
K911175	SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)	Apr 05, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K905770	CIBA CORNING ACS FERRITIN IMMUNOASSAY	Mar 12, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K904822	ELEGANCE FERRITIN ELISA	Nov 29, 1990	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K901075	LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.	Apr 02, 1990	Substantially Equivalent	London Diagnostics, Inc.
K896585	MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT	Dec 04, 1989	Substantially Equivalent	Medix Biotech, Inc.
K895872	LAN.0800Q/2800Q	Oct 17, 1989	Substantially Equivalent	Amersham Corp.
K892362	AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)	May 09, 1989	Substantially Equivalent	Amersham Corp.
K885074	AFFINITY(TM) FERRITIN IMMUNIT(TM)	Jan 04, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K884683	FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY	Dec 27, 1988	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K883746	MICROMEDIC FERRITIN IRMA KIT	Oct 27, 1988	Substantially Equivalent	Icn Micromedic Systems
K874203	AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800	Jan 27, 1988	Substantially Equivalent	Amersham Corp.
K874572	ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM	Dec 02, 1987	Substantially Equivalent	Nichols Institute Diagnostics
K874031	IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5	Nov 25, 1987	Substantially Equivalent	Diagnostic Products Corp.
K873573	CIBA CORNING MAGIC LITE FERRITIN	Oct 07, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K871489	DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM	Jun 12, 1987	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K870570	FERRITIN MAB SOLID PHASE COMPONENT SYSTEM	Mar 12, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870107	COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS	Feb 10, 1987	Substantially Equivalent	Diagnostic Products Corp.
K864437	BECKMAN EPSILON(TM) FERRITIN TEST KIT	Jan 16, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K863345	TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY	Oct 08, 1986	Substantially Equivalent	Hybritech, Inc.
K863487	QUANTIMUNE(R) FERRITIN IRMA	Oct 01, 1986	Substantially Equivalent	Bio-Rad
K862960	PHASE II FERRITIN RADIOIMMUNOASSAY KIT	Aug 27, 1986	Substantially Equivalent	Medical & Scientific Designs, Inc.
K862014	IMMPULSE FERRITIN ASSAY REAGENT	Jun 19, 1986	Substantially Equivalent	Sclavo, Inc.
K860137	ENZYMUN-TEST FERRITIN	Mar 28, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K844158	STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY	Nov 19, 1984	Substantially Equivalent	American Dade
K841925	DSL FERRITIN IRMA	May 25, 1984	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K830580	DIAGNON FERRITIN 125 I RIA KIT	May 05, 1983	Substantially Equivalent	Iagnon Corp.
K830591	CORNING FERRITIN 125I RADIOIMMUNOASSAY	Mar 24, 1983	Substantially Equivalent	Corning Medical & Scientific
K823871	TANDEM-E -FER IMMUNOENZYMETRIC KIT	Feb 25, 1983	Substantially Equivalent	Hybritech, Inc.
K823275	AUTOPAK FERRITIN TEST DELIVERY SYS	Dec 03, 1982	Substantially Equivalent	Micromedic Systems
K822472	ANTISERA TO HUMAN FERRITIN	Sep 30, 1982	Substantially Equivalent	Kent Laboratories, Inc.
K812901	125I FERRITIN RADIOIMMUNOASSAY KIT	Dec 30, 1981	Substantially Equivalent	Bio-Ria
K812786	FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS	Oct 23, 1981	Substantially Equivalent	Corning Medical & Scientific
K812597	FERRITIN KIT	Oct 19, 1981	Substantially Equivalent	Hybritech, Inc.
K812056	SPECTRO FEIRITIN	Aug 12, 1981	Substantially Equivalent	Ramco Laboratories, Inc.
K811880	LEECO FERRITIN-QUANT DIAG. TEST KIT	Jul 16, 1981	Substantially Equivalent	Leeco Diagnostics, Inc.
K811808	AUTOPAK-12 FERRITIN KIT	Jul 10, 1981	Substantially Equivalent	Micromedic Systems
K811804	FERRITIN RIA KIT	Jul 10, 1981	Substantially Equivalent	Amersham Corp.
K801989	NORDICLAB FERRITIN IRMA TEST	Sep 16, 1980	Substantially Equivalent	Nordiclab Intl.
K801676	FERRIZYME FERRITIN ENZYME IMMUNOASSAY	Aug 20, 1980	Substantially Equivalent	Abbott Laboratories
K801580	FERRITIN RIA KIT	Aug 13, 1980	Substantially Equivalent	Diagnostic Products Corp.
K800657	FERRITIN CONTROLS CODE QAS.104	Apr 16, 1980	Substantially Equivalent	Amersham Corp.
K800299	FERRITIN RIA KIT	Mar 03, 1980	Substantially Equivalent	Amersham Corp.
K792449	CENTRIA FERRITIN RIA	Dec 31, 1979	Substantially Equivalent	Union Carbide Corp.
K792442	FERRITIN RADIOIMMUNOASSAY	Dec 18, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K791860	FERRITIN RIA KIT	Dec 06, 1979	Substantially Equivalent	Cis Radiopharmaceuticals, Inc.
K790490	NEIA-FERRITIN ENZYMEIMMUNASSAY KIT	Apr 23, 1979	Substantially Equivalent	New England Immunology Assoc.
K790447	VENTRE/SEP FERRITIN RIA	Apr 23, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K780490	NEIA-FERRITIN ENZYMEIMMUNOASSAY	Apr 10, 1978	Substantially Equivalent	New England Immunology Assoc.
K770702	IN VITRO FERRITIN RIA TEST	Jun 17, 1977	Substantially Equivalent	Clinical Assays, Inc.